There are cases in which compliance of taking an orally administered agent drops by an unpleasant feeling due to the drug being bitter, astringent or the like, nausea or vomiting due to taking the drug, or refusal to take the drug. Various forms of orally administered agents have thus been developed.
Typically used forms of orally administered agents are solid preparations such as tablets and capsules. However, these solid preparations are difficult to swallow as it is, and must generally be taken with a large amount of water; even when taken with a large amount of water, there are cases in which swallowing is still difficult. There are thus cases in which compliance of taking the drug drops. Moreover, there are cases in which a solid preparation mistakenly gets stuck in the trachea, and cases in which a solid preparation sticks to the esophagus and hence an esophageal ulcer forms in this place.
In particular, it may not be possible for elderly people and infants to swallow a solid preparation, and hence a drop in compliance of taking the drug is often seen. Moreover, in the case of bedridden patients, after putting the solid preparation into the patient's mouth, giving water slowly, and then waiting a while, it is necessary for the care provider to feel around with his/her own fingers inside the patient's mouth to check that the solid preparation is not still there, and thus the work of checking whether or not the preparation has been taken is very burdensome.
To improve upon the difficulty of swallowing a solid preparation, and thus increase the ease and safety of taking the solid preparation, one can envisage making the form into a semi-solid form such as a jelly. However, a semi-solid preparation such as a jelly is difficult to realize due to the problems that a lot of moisture is contained, and hence the stability of the drug drops (particularly in the case of a readily hydrolyzable drug), sterile handling is difficult during manufacture and storage, and packaging is expensive.
On the other hand, by processing an orally administered agent into a film-shaped preparation (sheet-shaped preparation), the moisture content in the preparation can be kept down, and hence the stability of the drug can be improved (particularly in the case of a readily hydrolyzable drug), handling becomes easy, and the packaging cost can be reduced.
Regarding such film-shaped preparations, film-shaped preparations for which an object is to make disintegration or dissolution occur rapidly in the mouth (Japanese Patent Application Laid-open No. H7-100186, Japanese Patent Application Laid-open No. H5-220203, Japanese Patent Application Laid-open No. H11-116469), and film-shaped preparations for which an object is to make handling of a minute amount of a drug easy (Japanese Patent Application Laid-open No. H5-124954) are known.